FDA Rejects Citizen Petitions for Over-the-Counter Hearing Aids The U.S. Food and Drug Administration (FDA) has rejected two citizen petitions that would eliminate the need for a medical evaluation or waiver prior to hearing aid purchase and create a class of over-the-counter (OTC) hearing aids. The petitions generated intense debate and strong opposition among hearing health professionals. “The ... Policy Analysis
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Policy Analysis  |   April 01, 2004
FDA Rejects Citizen Petitions for Over-the-Counter Hearing Aids
Author Notes
  • Susan Boswell, an assistant managing editor of The ASHA Leader, can be reached at sboswell@asha.org.
    Susan Boswell, an assistant managing editor of The ASHA Leader, can be reached at sboswell@asha.org.×
Article Information
Regulatory, Legislative & Advocacy / Policy Analysis
Policy Analysis   |   April 01, 2004
FDA Rejects Citizen Petitions for Over-the-Counter Hearing Aids
The ASHA Leader, April 2004, Vol. 9, 1-11. doi:10.1044/leader.PA.09082004.1
The ASHA Leader, April 2004, Vol. 9, 1-11. doi:10.1044/leader.PA.09082004.1
The U.S. Food and Drug Administration (FDA) has rejected two citizen petitions that would eliminate the need for a medical evaluation or waiver prior to hearing aid purchase and create a class of over-the-counter (OTC) hearing aids. The petitions generated intense debate and strong opposition among hearing health professionals.
“The opposition from the hearing health care community came from a concern for the consumer,” said Roberta Aungst, ASHA vice president for professional practices in audiology. “We have all seen clients who jpurchased a mail-order hearing device and then had to seek help from a local audiologist.”
Citing a concern for public health, the FDA turned down a petition by Mead Killion, president of Illinois-based Etymotic Research, that called for a “one-size-fits-most” hearing aid that could be sold over-the-counter as an affordable alternative to custom hearing aids. The device, which employs existing technology, would have a peak output of 115 dB or less to provide a margin of safety from high-intensity sounds, and would cost an estimated $100 to $300, according to the Aug. 7, 2003 petition.
A petition filed the following day by Gail Gudmundsen, president of Gudhear, Inc., sought to eliminate the federal regulations that require adults to obtain a medical evaluation of their hearing loss within six months prior to purchase of a hearing aid, or to sign a waiver in lieu of an evaluation. Gudmundsen proposed that the user instructional brochure inform consumers that a hearing aid will not restore normal hearing, prevent progressive hearing loss, or improve the underlying causes of organic hearing loss. The proposed language would also advise consumers that some types of hearing loss can be medically corrected, and provide eight “red flag” indicators for conditions that should be medically evaluated.
Consumer Protection Concerns
The FDA, however, was unconvinced that listing “red flag” indicators would provide sufficient consumer protection. In nearly identical letters to Gudmundsen and Killion dated Feb. 13, Beverly Chernaik Rothstein, acting deputy director for regulation and policy of the FDA’s Center for Devices and Radiological Health, stated that “if prospective purchasers of hearing aids are not examined by a physician prior to using a hearing aid, ‘red flag’ ear conditions will go undiagnosed.”
“Several of these red flag conditions cannot be diagnosed by the patient and instead require physician examination or audiometric studies,” Rothstein stated in the letters. “Without appropriate screening by a licensed physician, persons with hearing loss may purchase hearing aids and may even experience some relief, while continuing to have serious medical conditions.”
Older adults are most likely to suffer as a result of the elimination of the medical examination and medical waiver requirements Rothstein said, citing research in the Journal of the American Medical Association. The study (Yueh et al., 2003) stated that up to 30% of elderly patients may have treatable hearing loss due to cerumen impaction and chronic otitis media.
In a written response to the FDA rulings prepared for the press, Killion and Gudmundsen countered that “the actual risks of skipping the [medical] exam are extremely small and rarely fatal. As one indication of how small the risk is, we allow consumers to assess the risk themselves and sign a waiver. There is no justification for the extra step unless it is simply to make sure the consumer reads the risk.”
In denying Killion’s petition for over-the-counter hearing aids, the FDA upheld the findings of the agency’s Interdepartmental Task Force on Hearing Aids that led to the 1977 Hearing Aid Rule.
The FDA clearly did not want to go back to the days prior to the rule. According to the findings of the task force that led to the regulations, misevaluation of a patient’s need for a hearing aid resulted in the sale of hearing aids that were ineffective and possibly unsafe-a major problem in the hearing aid delivery system.
“It is important for individuals with hearing loss to obtain a comprehensive audiologic evaluation from an ASHA-certified audiologist,” Aungst said. “If amplification is indicated, the audiologist can provide a hearing aid assessment as part of an individualized audiologic rehabilitation program with the goal of assisting the individual in adapting to and fully benefiting from amplification.”
Organizations representing audiology, otolaryngology, and hearing instrument specialists voiced strong opposition to the petitions prior to their denial. After soliciting member input and reviewing the issues, ASHA chose not to submit comments based on disucssion with the FDA that it was unlikely that the agency would support the requested changes. ASHA members were informed about the petitions when they were filed and provided with information as well as how to obtain copies of the petitions through the FDA Web site and the process for submitting comments in response.
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April 2004
Volume 9, Issue 8